Turnstone Biologics is a clinical stage biotechnology company developing new medicines to treat and cure solid tumors by pioneering a differentiated approach with a clinically validated technology, tumor infiltrating lymphocyte (TIL) therapy. Turnstone’s innovative TIL therapy, which is designed to extend the efficacy of TILs to multiple solid tumor indications by selecting and manufacturing the most potent tumor-reactive T-cells (Selected TILs) for tumor eradication, represents the Company’s foundational therapeutic modality driving its cancer immunotherapy pipeline. The Company recently commenced two clinical trials in various solid tumor types with its lead Selected TIL therapy candidate, TIDAL-01, one of which is in collaboration with Moffitt Cancer Center. Turnstone is developing additional strategies to further potentiate the clinical benefit of Selected TILs, including use in combination with their novel viral immunotherapy.
At Turnstone, the science drives decision-making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected. Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’. If you are a passionate person, and our science excites you – this opportunity may be for you.
The Scientist/Engineer, Senior Scientist/Engineer will be key contributor to process development for the cell therapy programs at Turnstone Biologics. Primary responsibilities include experimental design, execution and analysis of studies focused on characterizing and improving Turnstone’s TIL cell therapy manufacturing processes. The candidate will also be responsible for authoring study protocols and reports, drafting GMP documentation, supporting technology transfer, and supporting the MSAT and manufacturing teams during GMP production. The role requires expertise in aseptic cell culture, use of standard equipment for cell therapy processing, data analysis and trending and, basic analytics for cell therapies. Essential to the role will be collaboration with cross functional stakeholders. The Scientist/Engineer, Senior Scientist/Engineer will collaborate with research, process development, manufacturing, quality and regulatory teams to ensure process development studies are effectively designed, executed, analyzed and reported. The position reports to the Associate Director, Process Development, and will be located in San Diego, CA.
Summary of Key Responsibilities:
- Lead design and execution of laboratory studies to support process design and development, characterization, and improvements
- Collaborate with the analytical development team to perform analytical test methods, including flow cytometry, on samples from process development studies
- Maintain detailed experimental records in lab notebooks, analyze and interpret data, and present data to cross functional teams in research, process development, manufacturing and quality
- Participate in cross-functional team meetings and report results to advance process development activities
- Support process technology transfer and qualification at contract manufacturing organizations
- Provide technical support to the internal manufacturing and QC teams during deviation and OOS investigations
- Author protocols, reports and SOPs to document development studies and enable efficient transfer of process improvements to manufacturing
- Utilize appropriate statistical methods to design studies and analyze development data
- Contribute to process sections of regulatory submissions and related information requests
- Provide mentorship and training to new and/or junior team members
- BS or MS in cell biology, immunology, biochemistry, molecular biology, biochemical engineering, bioengineering or related disciplines with at least 5 years process development experience. Role commensurate with experience and background
- Demonstrated ability to collaborate with cross functional stakeholders in the design and execution of process development studies across multiple platforms commonly used in industrial cell therapy applications
- Technical expertise in aseptic cell culture
- Technical expertise with T-cell culture preferred
- Prior experience with industrial cell therapy manufacturing equipment
- Prior experience with flow cytometry and cell-based functional assays preferred
- Prior experience in technology transfer to internal or contract manufacturing teams preferred
- Prior experience with statistical analysis of data, design of experiments and use of JMP software preferred
- Working knowledge of cGMPs and relevant regulatory guidelines, with experience in authorship of regulatory submissions preferred
- Prior experience working across multiple projects in a fast paced, hands-on environment
- Exceptional written and oral communication skills
The anticipated salary range for this role is $95,000 - $145,000.
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.